MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION GUIDEZILLA; CATHETER, PERCUTANEOUS

Model Number 1867

Device Problems Device Damaged by Another Device (2915); Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by the manufacturer.The hypotube, collar, distal shaft and tip was microscopically and visually inspected.Visual inspection revealed kinks to the hypotube 30.7 cm and 33.4 cm from the handle.The collar is separated, and the ptfe is still holding the two ends together.There are multiple flat spots along the distal shaft and the tip is flattened.Microscopic inspection revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damages along the device that could have contributed to the difficulty to advance another device through the catheter.

Event Description

Reportable based on device analysis completed 26july2019.It was reported that stent could not advance through this device.The target lesion area was located in a tortuous artery.A 145 guidezilla guide extension catheter was selected for use.Pre-dilation was performed.A 4 x 38 mm non bsc stent was attempted to be advanced through the guidezilla.The stent could not fully advance through the guidezilla and the stent was removed.It was observed that the stent was damaged.The guidezilla was removed and another 4 x 38 mm non bsc stent was implanted without issue.No patient complications were reported and the patient's status was stable.However, returned analysis revealed a damaged collar.

• Brand Name: GUIDEZILLA
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 8910480
• MDR Text Key: 154890461
• Report Number: 2134265-2019-09921
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 08714729839859
• UDI-Public: 08714729839859
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K123765
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2020
• Device Model Number: 1867
• Device Catalogue Number: 1867
• Device Lot Number: 0022580889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ONIX - STENT
• Patient Age: 76 YR